Ischemic StrokePhase 2NCT00796887
Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
A Phase 2 study testing Extended-Release Niacin in people with Ischemic Stroke, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, and to explore the possible benefit of extended-release niacin (Niaspan®) in attempting to improve the recovery of patients after ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Extended-Release Niacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical ischemic stroke able to enroll between 72 hours and 7 days after symptom onset.
- Patients age 18-85, inclusive.
- NIHSS score of 4-21, inclusive, prior to treatment.
- Signed IRB-approved informed consent by patient or authorized representative.
Who cannot join
- General
- Participation in another study with an investigational drug or device.
- Women known to be pregnant, lactating, or of childbearing potential with a positive urine beta-HCG.
- Patients using niacin within the 7 days previous to their stroke.
- Safety Related
- Unstable angina.
Show all 28Show fewer
- Acute Myocardial infarction.
- Concurrent arterial bleeding.
- Active peptic ulcer disease.
- Platelet count less than 100,000 per microliter.
- Internationally Normalized Ratio (INR) greater than 1.3 without use of warfarin.
- Concurrent use of bile acid sequestrants (colestipol and cholestyramine)
- Baseline systolic blood pressure less than 100 mmHg.
- History of significant hepatic dysfunction.
- Allergy or hypersensitivity to aspirin.
- Concurrent use of amiodarone, gemfibrozil, fibrate or other bile acid resin, cyclosporine, itraconazole, ketaconazole, telithromycin, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, danazol.
- Allergy or hypersensitivity to extended-release niacin.
- Allergy or hypersensitivity to statin agents.
- Potentially Interfering with Outcomes Assessment
- Prior history of dementia.
- Patients without fixed address or those deemed unlikely to present for follow-up by the investigator.
- Patients whose life expectancy is less than 24 weeks.
- Pre-stroke modified Rankin score>2.
- Glucose less than 50 mg/dl.
- Other serious illness (e.g., severe hepatic, cardiac, or renal failure; or a complex disease that may confound treatment assessment).
- Imaging Related
- Evidence of primary intra-parenchymal hemorrhage on initial neuroimaging study.
- Neuroimaging evidence of a nonvascular cause for the neurological symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Randomized, Double-Blinded, Placebo-Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
The purpose of this study is to determine the safety, tolerability, and to explore the possible benefit of extended-release niacin (Niaspan®) in attempting to improve the recovery of patients after ischemic stroke.
Read the detailed description
The investigators are interested in extended-release niacin (Niaspan®) and its potential restorative role after ischemic stroke. At Henry Ford Hospital in Detroit, Michigan, extended-release niacin (Niaspan®) has been shown to improve the functional outcomes of rats when administered during the first two weeks after ischemic stroke onset. Such results are encouraging and warrant further investigation in humans. The specific aims of this study are to prospectively evaluate the use of extended-release niacin (Niaspan®) in a phase II clinical trial in patients with subacute ischemic stroke. The investigators will assess the safety and tolerability of Niaspan® and evaluate outcomes among treated patients at 24 weeks after ischemic stroke onset. This will be a randomized, double-blinded, placebo-controlled, safety, tolerability, and exploratory efficacy study of extended-release niacin (Niaspan®) in subacute ischemic stroke patients with both low HDL-C and normal HDL-C in cohort sizes of 16 patients. A total enrollment of 48 patients is planned. Patients who are between 72 hours and 7 days from stroke onset will receive Niaspan® 500mg, 1000mg, or placebo daily for a period of 24 weeks. Evaluation of potential safety and tolerability in subacute ischemic stroke patients will be made during the course of treatment and at formal visits at 6, 12, and 24 weeks. The primary safety measures will be death, recurrent stroke, myocardial infarction, and neurological worsening during treatment. Exploratory analysis will include functional outcomes on the NIHSS scores, modified Rankin scores, and Barthel indices at 24 weeks. The goal of this study is to improve the outcomes from ischemic stroke, using a safe and effective novel strategy of restoration, which has been translated from basic laboratory studies.
- Conditions
- Ischemic Stroke
- Being tested
- Extended-Release Niacin, Placebo
- Keywords
- Ischemic Stroke, Recovery of Function, Extended-release niacin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-Release NiacinDrug
Also called Niaspan®
500mg or 1000mg tablet once daily
PlaceboDrug
Placebo tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Niaspan® 500mg | Experimental | Extended-release niacin 500mg daily Receives: Drug: Extended-Release Niacin |
| Niaspan® 1000mg | Experimental | Extended-release niacin 1000mg daily Receives: Drug: Extended-Release Niacin |
| Placebo | Placebo comparator | Placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serious Adverse Events
Analysis of the frequency and type of serious adverse events among patients in each study arm/group
Measured: 24 weeks
Secondary outcomes (1)
Functional Recovery
Exploratory efficacy analysis of the differences in functional recovery between each study arm as measured using the National Institutes of Stroke Scale score. The National Institutes of Health Stroke Scale score is a 15-item neurological examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored on a 3- to 5-point scale, with 0 as normal, and there is an allowance for untestable items. Scores range from 0 to 42, with higher scores indicating greater severity
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startApr 2009
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Study was stopped early due to limitations in funding. As a result, the sample size was insufficient for meaningful exploration of functional outcomes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew N. Russman, D.O., Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796887
- Sponsor's protocol ID
- HFHS-5284
- Status last verified
- Aug 2026
- First submitted
- 21 Nov 2008
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double-Blinded, Placebo-Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
- ClinicalTrials.gov ID
- NCT00796887
- Acronym / sponsor ID
- HFHS-5284
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Recovery of Function, Extended-release niacin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped early due to limitations in funding. As a result, the sample size was insufficient for meaningful exploration of functional outcomes
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability, and to explore the possible benefit of extended-release niacin (Niaspan®) in attempting to improve the recovery of patients after ischemic stroke.
Detailed description
The investigators are interested in extended-release niacin (Niaspan®) and its potential restorative role after ischemic stroke. At Henry Ford Hospital in Detroit, Michigan, extended-release niacin (Niaspan®) has been shown to improve the functional outcomes of rats when administered during the first two weeks after ischemic stroke onset. Such results are encouraging and warrant further investigation in humans. The specific aims of this study are to prospectively evaluate the use of extended-release niacin (Niaspan®) in a phase II clinical trial in patients with subacute ischemic stroke. The investigators will assess the safety and tolerability of Niaspan® and evaluate outcomes among treated patients at 24 weeks after ischemic stroke onset. This will be a randomized, double-blinded, placebo-controlled, safety, tolerability, and exploratory efficacy study of extended-release niacin (Niaspan®) in subacute ischemic stroke patients with both low HDL-C and normal HDL-C in cohort sizes of 16 patients. A total enrollment of 48 patients is planned. Patients who are between 72 hours and 7 days from stroke onset will receive Niaspan® 500mg, 1000mg, or placebo daily for a period of 24 weeks. Evaluation of potential safety and tolerability in subacute ischemic stroke patients will be made during the course of treatment and at formal visits at 6, 12, and 24 weeks. The primary safety measures will be death, recurrent stroke, myocardial infarction, and neurological worsening during treatment. Exploratory analysis will include functional outcomes on the NIHSS scores, modified Rankin scores, and Barthel indices at 24 weeks. The goal of this study is to improve the outcomes from ischemic stroke, using a safe and effective novel strategy of restoration, which has been translated from basic laboratory studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Niaspan® 500mg | Experimental | Drug: Extended-Release NiacinExtended-release niacin 500mg daily |
| Niaspan® 1000mg | Experimental | Drug: Extended-Release NiacinExtended-release niacin 1000mg daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinical ischemic stroke able to enroll between 72 hours and 7 days after symptom onset.
- Patients age 18-85, inclusive.
- NIHSS score of 4-21, inclusive, prior to treatment.
- Signed IRB-approved informed consent by patient or authorized representative.
Key exclusion criteria (28 listed)
- General
- Participation in another study with an investigational drug or device.
- Women known to be pregnant, lactating, or of childbearing potential with a positive urine beta-HCG.
- Patients using niacin within the 7 days previous to their stroke.
- Safety Related
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended-Release NiacinAlso: Niaspan®500mg or 1000mg tablet once daily | Drug | Niaspan® 1000mg, Niaspan® 500mg |
| PlaceboPlacebo tablet once daily | Drug | Placebo |
Primary outcome
Number of Participants With Serious Adverse Events
Time frame: 24 weeks
Analysis of the frequency and type of serious adverse events among patients in each study arm/group
1 secondary outcome
Functional Recovery
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew N. Russman, D.O. principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extended-Release Niacin in people with Ischemic Stroke, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Adverse Events (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.